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This study aims to evaluate the levels of leptin in both saliva and serum samples of patients diagnosed with oral lichen.
Oral lichen planus is a frequently encountered chronic muco-cutaneous condition with a high prevalence rate. The condition can be classified as an autoimmune disorder.Although the exact cause of this condition is unknown, some potential risk factors should be taken into account, such as systemic disorders, psychogenic diseases, dental restorations, and certain medications.
The oral lesions exhibit a mostly bilateral pattern, often manifesting in the inner buccal mucosa. The condition can be classified into three distinct forms, namely the reticular form, atrophic form, and bullous-erosive form.
The condition is classified as a premalignant lesion due to its significant likelihood of undergoing malignant transformation. The disease is characterized by the presence of T-lymphocyte infiltration in the basal cell layer of the epithelium and the presence of cytoid bodies, which are distinct histopathologic markers.
Leptin, a hormone generated by adipocytes, is involved in immunological responses and contributes to the development of autoimmunity. The presence of dyslipidemia has been found to be associated with lipoprotein (LP) abnormalities. Consequently, this study was undertaken to assess the blood leptin levels and lipid profile in individuals with LP. Leptin, a polypeptide hormone, is produced and released by white adipose tissue.
Multiple research have substantiated an increase in leptin levels among persons exhibiting elevated body mass index (BMI) and a higher percentage of total body fat. Additionally, it is involved in the cellular immune response and facilitates the development of autoimmunity.
There is a proposition suggesting that leptin has a role in the promotion of cytokine generation and modulation of helper T cells, potentially implicating its involvement in the pathogenesis of psoriasis. The available information about leptin status in dermatological illnesses other than psoriasis is currently sparse. It is plausible that it may have a significant role in the pathogenesis of lichen planus.
However, there is a lack of literature regarding the levels of leptin in LP. There is an association between dyslipidemia and LP. Numerous investigations have consistently demonstrated notable deviations in lipid profile levels between individuals with LP and those in normal, healthy control cohorts. These findings have led researchers to posit a correlation between chronic inflammation and dyslipidemia, hence heightening the susceptibility to cardiovascular illnesses.
The potential impact of leptin on the progression of LP is being investigated. The objective of this study was to conduct a comparative analysis of blood leptin levels between individuals recently diagnosed with LP and a control group consisting of healthy individuals. Additionally, an assessment was conducted to examine the correlation between leptin levels, lipid profile, and the length of illness.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral lichen planus patients | Assessment of salivary and serum leptin levels |
| |
| Healthy control group | Assessment of salivary and serum leptin levels |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Leptin | Diagnostic Test | Assessment of salivary and serum leptin levels in oral lichen planus patients and healthy controls |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum Leptin Level | Assessment of serum leptin levels in in oral lichen planus patients | Baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Salivary Leptin Levels | Assessment of salivary leptin levels in oral lichen planus patients | Baseline |
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Inclusion Criteria:
Exclusion Criteria:
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OLP patients and healthy controls were selected will be selected from "out-patient clinic" of Oral Medicine, Periodontology and Oral Diagnosis Department ;Faculty of Dentistry, Cairo university and from "out-patient" of Boulak El Dakroor general hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Weam Ah Rashwan, PHD | Cairo University | Study Director |
| Olfat Ga Shaker, PHD | Cairo University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo university | Cairo | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35685585 | Background | Aryanian Z, Shirzadian A, Hatami P, Dadras H. High Incidence of Metabolic Syndrome Components in Lichen Planus Patients: A Prospective Cross-Sectional Study. Int J Clin Pract. 2022 Jan 31;2022:7184678. doi: 10.1155/2022/7184678. eCollection 2022. | |
| 15749839 | Background | Matarese G, Moschos S, Mantzoros CS. Leptin in immunology. J Immunol. 2005 Mar 15;174(6):3137-42. doi: 10.4049/jimmunol.174.6.3137. |
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| ID | Type | URL | Comment |
|---|---|---|---|
| Study Protocol | View IPD |
There is no washout that has been done; some of the enrolled participants were excluded because they were currently on systemic steroid medication or taking topical steroids for lesions.
The recruitment process has taken 1 year, starting from December 2023 till December 2024; all recruitment processes were done in the Cairo University outpatient clinic.
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| ID | Title | Description |
|---|---|---|
| FG000 | Oral Lichen Planus Patients | Assessment of salivary and serum leptin levels Leptin: Assessment of salivary and serum leptin levels in oral lichen planus patients |
| FG001 | Healthy Control Group | Assessment of salivary and serum leptin levels Leptin: Assessment of salivary and serum leptin healthy controls |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Oral Lichen Planus Patients | Assessment of salivary and serum leptin levels Leptin: Assessment of salivary and serum leptin levels in oral lichen planus patients and healthy controls |
| BG001 | Healthy Control Group |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Leptin Level | Assessment of serum leptin levels in in oral lichen planus patients | Levels of leptin in serum of patients with active oral lichen planus | Posted | Mean | Standard Deviation | ng/ml | Baseline |
|
Adverse event data were collected over a period of 3 months following the intervention
There are no serious risk events because the trial is simple: taking saliva or taking a blood sample is easy, and none of this can cause mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Oral Lichen Planus Patients | Patients with active symptomatic oral lichen planus |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Bahaa Mahmoud Fawzy | Cairo university | +201033559646 | bahaamust66@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 18, 2023 | Mar 5, 2025 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D017676 | Lichen Planus, Oral |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D008010 | Lichen Planus |
| D017512 | Lichenoid Eruptions |
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ELISA
Assessment of salivary and serum leptin levels
Leptin: Assessment of salivary and serum leptin levels in oral lichen planus patients and healthy controls
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body mass index | Mean | Standard Deviation | Kg/m^2 |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Salivary Leptin Levels | Assessment of salivary leptin levels in oral lichen planus patients | Posted | Mean | Standard Deviation | ng/ml | Baseline |
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 0 |
| 39 |
| EG001 | Healthy Control Subjects | Healthy controls that not have any active aystemic disease | 0 | 39 | 0 | 39 | 0 | 39 |
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| D017444 |
| Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |